FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2101599
·
Received May 11, 2011
Report
- Report Number
- 1720753-2011-07183
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 27, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE CANDLE STICK WAS CLEANED AND THE CANDLES WERE REGREASED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM MADE A POPPING SOUND THEN THE SCREENS WENT BLACK. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |